The National Heart, Lung, and Blood Institute Pediatric Circulatory Support Program

The Pediatric Circulatory Support Program (PCSP) of the National Heart, Lung, and Blood Institute (NHLBI) was established to fund the development of novel circulatory support devices for children with medically refractory heart failure.1 Before this, developers of circulatory support devices found little incentive to enter the pediatric market because of the small patient numbers that are generally insufficient to justify the significant costs required to develop these devices. As a result of the lack of availability of new devices for circulatory support of pediatric patients, extracorporeal membrane oxygenation (ECMO), which first had been used clinically in the 1960s, remained the most commonly used modality to support these critically ill children during the next 40 years.2 The most attractive feature of ECMO for pediatric circulatory support is its ability to be used in even the smallest infants and neonates. However, ECMO support is characterized by thromboembolic complications and sepsis in a significant percentage of patients.3 Perhaps most importantly, ECMO has generally only been suitable for short-term support, limiting its usefulness as a bridge to transplantation, and the size and extracorporeal configuration of the system components usually limit its use to the intensive care unit setting and preclude ambulation and rehabilitation during support.In recognition of the limitations of the existing devices for pediatric mechanical circulatory support and the limitations for the entry of device companies into the pediatric market, the NHLBI established the PCSP to “perform basic and applied research to develop novel circulatory assist devices or other bioengineered systems for infants and children with congenital and acquired cardiovascular disease who experience cardiopulmonary failure and circulatory collapse.”4 Because the PCSP was a development program for new devices to address a broad goal (circulatory support for pediatric heart …